03.17.25 -- February 2025 — CDMO Opportunities And Threats Report

The manufacturing process for autologous therapies is complex and highly customized, requiring well-orchestrated transport, careful planning, and tight control of many discrete and manual processing steps.

Here, we evaluate the stability of these variant poly(A) regions and the biological activity of the mRNA containing the variant poly(A) tails made from these templates.

This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.

Explore how TARGATT gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

Ensure drug stability and safety with forced degradation and photo-stability testing per ICH and FDA standards, identifying degradation pathways and light exposure risks.

Explore how the Alerion™ Microbubble System surpasses magnetic methods in T cell recovery, speed, and scalability, delivering superior cell quality with Akadeum’s microbubble technology.

Lonza has further improved its platform process with the creation of engineered plasmids that afford significantly higher titers and productivity levels compared to standard systems.

Uncover how our collaborative approach positions us as an extended workbench for our partners, enabling faster, more effective solutions for patients.

Kincell Bio is a trusted manufacturing services partner for cell therapy companies, providing expert services including access to CMC development and clinical manufacturing for cell therapy.